Composition and methods for sanitization
AssigneeGenzyme Corporation
InventorsJoseph P. Kutzko, Ryan F. Wollensak
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Abstract
The present technology relates to a novel sanitization method for chromatography media and supporting equipment comprising treatment with a sanitization/sterilization solution comprising acetic acid and hexylene glycol.
Claims42
A method for sanitizing or sterilizing chromatography media and/or supporting equipment, comprising contacting the chromatography media and/or supporting equipment with a sanitization or sterilization solution comprising a carboxylic acid and about 20% hexylene glycol, wherein the concentration of the carboxylic acid is from about 40 mM to about 200 mM.
A method for eluting a target analyte bound to a chromatography media, comprising contacting the chromatography media with an elution buffer comprising a carboxylic acid and about 20% hexylene glycol, wherein the concentration of the carboxylic acid is from about 40 mM to about 200 mM.
A method for sanitizing or sterilizing chromatography media and/or supporting equipment, comprising contacting the chromatography media and/or supporting equipment with a sanitization or sterilization solution comprising a carboxylic acid and hexylene glycol, such that the pH of this solution is ≤3.5, wherein this method provides a high degree of bacteria, spore, and/or mold inactivation or killing within 1 hour of treatment with the solution.
A method for eluting a target analyte bound to a chromatography media, comprising contacting the chromatography media with an elution buffer comprising a carboxylic acid and hexylene glycol, such that the pH of this buffer is ≤3.5, wherein the method provides improved product yield and peak sharpness.
The method of any one of any one of the preceding claims, wherein the concentration of hexylene glycol is about 20%.
The method of any one of the preceding claims, wherein the chromatography is an affinity chromatography.
A method of increasing the lifetime of a chromatography media, comprising sanitizing or sterilizing the chromatography media with a solution comprising about 65 mM acetic acid and about 20% hexylene glycol, wherein the method allows the lifetime of the chromatography media to be increased by at least about 10% compared to sanitizing or sterilizing the chromatography media with at least one of:
- (i) gamma irradiation or (ii) a buffer comprising sodium hydroxide.
The method of claim 31, wherein the chromatography media comprises at least one of:
- an affinity resin, a resin that is based on protein A or a variant thereof, a resin that is based on protein G or a variant thereof.
A solution comprising 65 mM acetic acid and 20% hexylene glycol.
Dependencies are inferred from the claim text.